Efficacy and safety of low-dose capecitabine plus docetaxel versus single-agent docetaxel in patients with anthracycline-pretreated HER2-negative metastatic breast cancer: results from the randomized phase III JO21095 trial
Purpose The randomized phase III JO21095 trial compared the efficacy and safety of low-dose capecitabine plus docetaxel combination therapy (XT) versus single-agent administration of docetaxel in anthracycline-pretreated HER2-negative metastatic breast cancer. Methods Patients were randomized to eit...
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| Veröffentlicht in: | Breast cancer research and treatment 2017-02, Vol.161 (3), p.473-482 |
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| creator | Yamamoto, Daigo Sato, Nobuaki Rai, Yoshiaki Yamamoto, Yutaka Saito, Mitsue Iwata, Hiroji Masuda, Norikazu Oura, Shoji Watanabe, Junichiro Hattori, Satoshi Matsuura, Yoshimasa Kuroi, Katsumasa |
| description | Purpose
The randomized phase III JO21095 trial compared the efficacy and safety of low-dose capecitabine plus docetaxel combination therapy (XT) versus single-agent administration of docetaxel in anthracycline-pretreated HER2-negative metastatic breast cancer.
Methods
Patients were randomized to either low-dose XT (capecitabine 825 mg/m
2
twice daily, days 1–14; docetaxel 60 mg/m
2
, day 1 every 3 weeks) or docetaxel (70 mg/m
2
, day 1 every 3 weeks). The primary objective was to demonstrate superior progression-free survival (PFS) with low-dose XT versus single-agent docetaxel. Overall survival (OS) and safety were secondary endpoints.
Results
In total, 162 patients were treated. Median PFS was 10.5 months with low-dose XT and 9.8 months with single-agent docetaxel (hazard ratio [HR] 0.62 [95% confidence interval (CI) 0.40–0.97];
p
= 0.03). The OS HR was 0.89 (95% CI 0.52–1.53;
p
= 0.68). Grade ≥3 treatment-related toxicities occurred in 74% of XT-treated patients and 76% of docetaxel-treated patients. The main differences in grade ≥3 treatment-related toxicities were hand-foot syndrome (7.3% of XT-treated patients vs 0% receiving docetaxel), fatigue/malaise (2.4 vs 10.0%), and peripheral edema (1.2 vs 7.5%). Dose modifications were required in 100% of low-dose XT and 49% of docetaxel patients. Toxicity-related treatment discontinuations occurred in 18 and 33%, respectively.
Conclusion
The improved PFS with low-dose XT versus docetaxel alone is consistent with higher-dose XT phase III experience, but the safety profile was more favorable and manageable. |
| doi_str_mv | 10.1007/s10549-016-4075-6 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_1868327410</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A493711959</galeid><sourcerecordid>A493711959</sourcerecordid><originalsourceid>FETCH-LOGICAL-c503t-b5aacfc3542707924910d52da8b9fc4cfcdc91552f4849fd4e6a674eea80b5623</originalsourceid><addsrcrecordid>eNp1ksFu1DAQhiMEokvhAbggS0iIS4qdjeOYW1UVuqhSJQTnyHHGu64cO9hOy_KyvAqzbIEtAuXgaOb7_xlbf1E8Z_SEUSreJEZ5LUvKmrKmgpfNg2LBuFiWomLiYbHAhiibljZHxZOUrimlUlD5uDiqWkp5VYtF8f3cGKuV3hLlB5KUgbwlwRAXbsshJCBaTaBtVr31QCY3JzIEDVl9BUduICYsJOvXDkq1Bp8PutaTSWWLxURubd7ghLyJOEo79CqnCDmCyjCQi_OPVelhjfQNkBH1KeO_Jj0CKeMOXkN8SyKk2aGbiWEkeQMk4tJhtN_QY9oo3Ha1WpEPVxWjkpMcrXJPi0dGuQTP7s7j4vO7809nF-Xl1fvV2ellqTld5rLnSmmjl7yuBBWyqiWjA68G1fbS6Bpbg5aM88rUbS3NUEOjGlEDqJb2vKmWx8Xrve8Uw5cZUu5GmzQ4pzyEOXWsbdplJWpGEX35F3od5uhxO6S4pDibyz_UWjnorDch49vtTLvTWi4FY_IndfIPCr8BRquDB2Oxfk_w6kCwAeXyJgU3Zxt8ug-yPahjSCmC6aZoRxW3HaPdLn3dPn0dhqzbpa9rUPPi7mZzP8LwW_ErbghUeyBhy68hHlz9v64_AAUh5so</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1859049159</pqid></control><display><type>article</type><title>Efficacy and safety of low-dose capecitabine plus docetaxel versus single-agent docetaxel in patients with anthracycline-pretreated HER2-negative metastatic breast cancer: results from the randomized phase III JO21095 trial</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Yamamoto, Daigo ; Sato, Nobuaki ; Rai, Yoshiaki ; Yamamoto, Yutaka ; Saito, Mitsue ; Iwata, Hiroji ; Masuda, Norikazu ; Oura, Shoji ; Watanabe, Junichiro ; Hattori, Satoshi ; Matsuura, Yoshimasa ; Kuroi, Katsumasa</creator><creatorcontrib>Yamamoto, Daigo ; Sato, Nobuaki ; Rai, Yoshiaki ; Yamamoto, Yutaka ; Saito, Mitsue ; Iwata, Hiroji ; Masuda, Norikazu ; Oura, Shoji ; Watanabe, Junichiro ; Hattori, Satoshi ; Matsuura, Yoshimasa ; Kuroi, Katsumasa</creatorcontrib><description>Purpose
The randomized phase III JO21095 trial compared the efficacy and safety of low-dose capecitabine plus docetaxel combination therapy (XT) versus single-agent administration of docetaxel in anthracycline-pretreated HER2-negative metastatic breast cancer.
Methods
Patients were randomized to either low-dose XT (capecitabine 825 mg/m
2
twice daily, days 1–14; docetaxel 60 mg/m
2
, day 1 every 3 weeks) or docetaxel (70 mg/m
2
, day 1 every 3 weeks). The primary objective was to demonstrate superior progression-free survival (PFS) with low-dose XT versus single-agent docetaxel. Overall survival (OS) and safety were secondary endpoints.
Results
In total, 162 patients were treated. Median PFS was 10.5 months with low-dose XT and 9.8 months with single-agent docetaxel (hazard ratio [HR] 0.62 [95% confidence interval (CI) 0.40–0.97];
p
= 0.03). The OS HR was 0.89 (95% CI 0.52–1.53;
p
= 0.68). Grade ≥3 treatment-related toxicities occurred in 74% of XT-treated patients and 76% of docetaxel-treated patients. The main differences in grade ≥3 treatment-related toxicities were hand-foot syndrome (7.3% of XT-treated patients vs 0% receiving docetaxel), fatigue/malaise (2.4 vs 10.0%), and peripheral edema (1.2 vs 7.5%). Dose modifications were required in 100% of low-dose XT and 49% of docetaxel patients. Toxicity-related treatment discontinuations occurred in 18 and 33%, respectively.
Conclusion
The improved PFS with low-dose XT versus docetaxel alone is consistent with higher-dose XT phase III experience, but the safety profile was more favorable and manageable.</description><identifier>ISSN: 0167-6806</identifier><identifier>EISSN: 1573-7217</identifier><identifier>DOI: 10.1007/s10549-016-4075-6</identifier><identifier>PMID: 28005247</identifier><identifier>CODEN: BCTRD6</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Aged ; Anthracyclines ; Anthracyclines - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Breast cancer ; Breast Neoplasms - drug therapy ; Breast Neoplasms - mortality ; Breast Neoplasms - pathology ; Cancer metastasis ; Cancer research ; Cancer therapies ; Capecitabine - administration & dosage ; Care and treatment ; Clinical Trial ; Clinical trials ; Comparative analysis ; Dosage and administration ; Drug therapy ; Female ; Humans ; Medicine ; Medicine & Public Health ; Metastasis ; Middle Aged ; Neoplasm Staging ; Oncology ; Product development ; Quality of Life ; Retreatment ; Survival Analysis ; Taxoids - administration & dosage ; Taxoids - therapeutic use ; Treatment Outcome</subject><ispartof>Breast cancer research and treatment, 2017-02, Vol.161 (3), p.473-482</ispartof><rights>Springer Science+Business Media New York 2016</rights><rights>COPYRIGHT 2017 Springer</rights><rights>Breast Cancer Research and Treatment is a copyright of Springer, 2017.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c503t-b5aacfc3542707924910d52da8b9fc4cfcdc91552f4849fd4e6a674eea80b5623</citedby><cites>FETCH-LOGICAL-c503t-b5aacfc3542707924910d52da8b9fc4cfcdc91552f4849fd4e6a674eea80b5623</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10549-016-4075-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10549-016-4075-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28005247$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yamamoto, Daigo</creatorcontrib><creatorcontrib>Sato, Nobuaki</creatorcontrib><creatorcontrib>Rai, Yoshiaki</creatorcontrib><creatorcontrib>Yamamoto, Yutaka</creatorcontrib><creatorcontrib>Saito, Mitsue</creatorcontrib><creatorcontrib>Iwata, Hiroji</creatorcontrib><creatorcontrib>Masuda, Norikazu</creatorcontrib><creatorcontrib>Oura, Shoji</creatorcontrib><creatorcontrib>Watanabe, Junichiro</creatorcontrib><creatorcontrib>Hattori, Satoshi</creatorcontrib><creatorcontrib>Matsuura, Yoshimasa</creatorcontrib><creatorcontrib>Kuroi, Katsumasa</creatorcontrib><title>Efficacy and safety of low-dose capecitabine plus docetaxel versus single-agent docetaxel in patients with anthracycline-pretreated HER2-negative metastatic breast cancer: results from the randomized phase III JO21095 trial</title><title>Breast cancer research and treatment</title><addtitle>Breast Cancer Res Treat</addtitle><addtitle>Breast Cancer Res Treat</addtitle><description>Purpose
The randomized phase III JO21095 trial compared the efficacy and safety of low-dose capecitabine plus docetaxel combination therapy (XT) versus single-agent administration of docetaxel in anthracycline-pretreated HER2-negative metastatic breast cancer.
Methods
Patients were randomized to either low-dose XT (capecitabine 825 mg/m
2
twice daily, days 1–14; docetaxel 60 mg/m
2
, day 1 every 3 weeks) or docetaxel (70 mg/m
2
, day 1 every 3 weeks). The primary objective was to demonstrate superior progression-free survival (PFS) with low-dose XT versus single-agent docetaxel. Overall survival (OS) and safety were secondary endpoints.
Results
In total, 162 patients were treated. Median PFS was 10.5 months with low-dose XT and 9.8 months with single-agent docetaxel (hazard ratio [HR] 0.62 [95% confidence interval (CI) 0.40–0.97];
p
= 0.03). The OS HR was 0.89 (95% CI 0.52–1.53;
p
= 0.68). Grade ≥3 treatment-related toxicities occurred in 74% of XT-treated patients and 76% of docetaxel-treated patients. The main differences in grade ≥3 treatment-related toxicities were hand-foot syndrome (7.3% of XT-treated patients vs 0% receiving docetaxel), fatigue/malaise (2.4 vs 10.0%), and peripheral edema (1.2 vs 7.5%). Dose modifications were required in 100% of low-dose XT and 49% of docetaxel patients. Toxicity-related treatment discontinuations occurred in 18 and 33%, respectively.
Conclusion
The improved PFS with low-dose XT versus docetaxel alone is consistent with higher-dose XT phase III experience, but the safety profile was more favorable and manageable.</description><subject>Adult</subject><subject>Aged</subject><subject>Anthracyclines</subject><subject>Anthracyclines - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - mortality</subject><subject>Breast Neoplasms - pathology</subject><subject>Cancer metastasis</subject><subject>Cancer research</subject><subject>Cancer therapies</subject><subject>Capecitabine - administration & dosage</subject><subject>Care and treatment</subject><subject>Clinical Trial</subject><subject>Clinical trials</subject><subject>Comparative analysis</subject><subject>Dosage and administration</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Humans</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Oncology</subject><subject>Product development</subject><subject>Quality of Life</subject><subject>Retreatment</subject><subject>Survival Analysis</subject><subject>Taxoids - administration & dosage</subject><subject>Taxoids - therapeutic use</subject><subject>Treatment Outcome</subject><issn>0167-6806</issn><issn>1573-7217</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1ksFu1DAQhiMEokvhAbggS0iIS4qdjeOYW1UVuqhSJQTnyHHGu64cO9hOy_KyvAqzbIEtAuXgaOb7_xlbf1E8Z_SEUSreJEZ5LUvKmrKmgpfNg2LBuFiWomLiYbHAhiibljZHxZOUrimlUlD5uDiqWkp5VYtF8f3cGKuV3hLlB5KUgbwlwRAXbsshJCBaTaBtVr31QCY3JzIEDVl9BUduICYsJOvXDkq1Bp8PutaTSWWLxURubd7ghLyJOEo79CqnCDmCyjCQi_OPVelhjfQNkBH1KeO_Jj0CKeMOXkN8SyKk2aGbiWEkeQMk4tJhtN_QY9oo3Ha1WpEPVxWjkpMcrXJPi0dGuQTP7s7j4vO7809nF-Xl1fvV2ellqTld5rLnSmmjl7yuBBWyqiWjA68G1fbS6Bpbg5aM88rUbS3NUEOjGlEDqJb2vKmWx8Xrve8Uw5cZUu5GmzQ4pzyEOXWsbdplJWpGEX35F3od5uhxO6S4pDibyz_UWjnorDch49vtTLvTWi4FY_IndfIPCr8BRquDB2Oxfk_w6kCwAeXyJgU3Zxt8ug-yPahjSCmC6aZoRxW3HaPdLn3dPn0dhqzbpa9rUPPi7mZzP8LwW_ErbghUeyBhy68hHlz9v64_AAUh5so</recordid><startdate>20170201</startdate><enddate>20170201</enddate><creator>Yamamoto, Daigo</creator><creator>Sato, Nobuaki</creator><creator>Rai, Yoshiaki</creator><creator>Yamamoto, Yutaka</creator><creator>Saito, Mitsue</creator><creator>Iwata, Hiroji</creator><creator>Masuda, Norikazu</creator><creator>Oura, Shoji</creator><creator>Watanabe, Junichiro</creator><creator>Hattori, Satoshi</creator><creator>Matsuura, Yoshimasa</creator><creator>Kuroi, Katsumasa</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope></search><sort><creationdate>20170201</creationdate><title>Efficacy and safety of low-dose capecitabine plus docetaxel versus single-agent docetaxel in patients with anthracycline-pretreated HER2-negative metastatic breast cancer: results from the randomized phase III JO21095 trial</title><author>Yamamoto, Daigo ; Sato, Nobuaki ; Rai, Yoshiaki ; Yamamoto, Yutaka ; Saito, Mitsue ; Iwata, Hiroji ; Masuda, Norikazu ; Oura, Shoji ; Watanabe, Junichiro ; Hattori, Satoshi ; Matsuura, Yoshimasa ; Kuroi, Katsumasa</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c503t-b5aacfc3542707924910d52da8b9fc4cfcdc91552f4849fd4e6a674eea80b5623</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anthracyclines</topic><topic>Anthracyclines - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - mortality</topic><topic>Breast Neoplasms - pathology</topic><topic>Cancer metastasis</topic><topic>Cancer research</topic><topic>Cancer therapies</topic><topic>Capecitabine - administration & dosage</topic><topic>Care and treatment</topic><topic>Clinical Trial</topic><topic>Clinical trials</topic><topic>Comparative analysis</topic><topic>Dosage and administration</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Humans</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metastasis</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Oncology</topic><topic>Product development</topic><topic>Quality of Life</topic><topic>Retreatment</topic><topic>Survival Analysis</topic><topic>Taxoids - administration & dosage</topic><topic>Taxoids - therapeutic use</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yamamoto, Daigo</creatorcontrib><creatorcontrib>Sato, Nobuaki</creatorcontrib><creatorcontrib>Rai, Yoshiaki</creatorcontrib><creatorcontrib>Yamamoto, Yutaka</creatorcontrib><creatorcontrib>Saito, Mitsue</creatorcontrib><creatorcontrib>Iwata, Hiroji</creatorcontrib><creatorcontrib>Masuda, Norikazu</creatorcontrib><creatorcontrib>Oura, Shoji</creatorcontrib><creatorcontrib>Watanabe, Junichiro</creatorcontrib><creatorcontrib>Hattori, Satoshi</creatorcontrib><creatorcontrib>Matsuura, Yoshimasa</creatorcontrib><creatorcontrib>Kuroi, Katsumasa</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><jtitle>Breast cancer research and treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yamamoto, Daigo</au><au>Sato, Nobuaki</au><au>Rai, Yoshiaki</au><au>Yamamoto, Yutaka</au><au>Saito, Mitsue</au><au>Iwata, Hiroji</au><au>Masuda, Norikazu</au><au>Oura, Shoji</au><au>Watanabe, Junichiro</au><au>Hattori, Satoshi</au><au>Matsuura, Yoshimasa</au><au>Kuroi, Katsumasa</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of low-dose capecitabine plus docetaxel versus single-agent docetaxel in patients with anthracycline-pretreated HER2-negative metastatic breast cancer: results from the randomized phase III JO21095 trial</atitle><jtitle>Breast cancer research and treatment</jtitle><stitle>Breast Cancer Res Treat</stitle><addtitle>Breast Cancer Res Treat</addtitle><date>2017-02-01</date><risdate>2017</risdate><volume>161</volume><issue>3</issue><spage>473</spage><epage>482</epage><pages>473-482</pages><issn>0167-6806</issn><eissn>1573-7217</eissn><coden>BCTRD6</coden><abstract>Purpose
The randomized phase III JO21095 trial compared the efficacy and safety of low-dose capecitabine plus docetaxel combination therapy (XT) versus single-agent administration of docetaxel in anthracycline-pretreated HER2-negative metastatic breast cancer.
Methods
Patients were randomized to either low-dose XT (capecitabine 825 mg/m
2
twice daily, days 1–14; docetaxel 60 mg/m
2
, day 1 every 3 weeks) or docetaxel (70 mg/m
2
, day 1 every 3 weeks). The primary objective was to demonstrate superior progression-free survival (PFS) with low-dose XT versus single-agent docetaxel. Overall survival (OS) and safety were secondary endpoints.
Results
In total, 162 patients were treated. Median PFS was 10.5 months with low-dose XT and 9.8 months with single-agent docetaxel (hazard ratio [HR] 0.62 [95% confidence interval (CI) 0.40–0.97];
p
= 0.03). The OS HR was 0.89 (95% CI 0.52–1.53;
p
= 0.68). Grade ≥3 treatment-related toxicities occurred in 74% of XT-treated patients and 76% of docetaxel-treated patients. The main differences in grade ≥3 treatment-related toxicities were hand-foot syndrome (7.3% of XT-treated patients vs 0% receiving docetaxel), fatigue/malaise (2.4 vs 10.0%), and peripheral edema (1.2 vs 7.5%). Dose modifications were required in 100% of low-dose XT and 49% of docetaxel patients. Toxicity-related treatment discontinuations occurred in 18 and 33%, respectively.
Conclusion
The improved PFS with low-dose XT versus docetaxel alone is consistent with higher-dose XT phase III experience, but the safety profile was more favorable and manageable.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>28005247</pmid><doi>10.1007/s10549-016-4075-6</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0167-6806 |
| ispartof | Breast cancer research and treatment, 2017-02, Vol.161 (3), p.473-482 |
| issn | 0167-6806 1573-7217 |
| language | eng |
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| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adult Aged Anthracyclines Anthracyclines - therapeutic use Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Breast cancer Breast Neoplasms - drug therapy Breast Neoplasms - mortality Breast Neoplasms - pathology Cancer metastasis Cancer research Cancer therapies Capecitabine - administration & dosage Care and treatment Clinical Trial Clinical trials Comparative analysis Dosage and administration Drug therapy Female Humans Medicine Medicine & Public Health Metastasis Middle Aged Neoplasm Staging Oncology Product development Quality of Life Retreatment Survival Analysis Taxoids - administration & dosage Taxoids - therapeutic use Treatment Outcome |
| title | Efficacy and safety of low-dose capecitabine plus docetaxel versus single-agent docetaxel in patients with anthracycline-pretreated HER2-negative metastatic breast cancer: results from the randomized phase III JO21095 trial |
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